FDA Retooling Organization at the Top

Yesterday, FDA Commissioner, Margaret Hamburg, announced some additions to the Agency’s top level organization that are aimed at getting a better handle on the regulation of the most complex parts of the medical industry in the United States. These changes include the appointment of the former Dean of the Dartmouth Medical School, Stephen Spielberg, to a newly created position of Deputy Commissioner of Medical Products and Tobacco, the promotion of Deborah Autor from Director of Compliance to Deputy Commissioner for Global Operations and Policy and the initiation of a search for a newly created Chief Operating Officer position.

Over the past years a number of key issues and changes in the Agency’s organization, not the least of which was that the Agency did not have a truly permanent Commissioner for a number of years before Dr. Hamburg’s arrival, had some negative effects. Even recently, the departure of Deputy Joshua Sharfstein to run Maryland’s health department could have been unsettling. In his tenure, from the time of his appointment by President Obama in 2009 until his recent departure, Dr. Sharfstein, along with Dr. Hamburg, had taken a very aggressive position in managing product safety issues, poor manufacturing processes and misleading advertising. It is expected that these new appointments will continue the FDA’s mission to strengthen and manage these important aspects.

Joel Falk is the Executive Vice President at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.